Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-20 @ 12:50 PM
Study NCT ID:
NCT03063918
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Pilot Study of a Personalized Dietary Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial studies how well personalized dietary intervention works in managing bowel dysfunction and improving quality of life in stage I-III rectosigmoid cancer survivors. Personalized dietary intervention may help people understand bowel symptoms, identify helpful and troublesome foods for bowel symptoms, adjust diets and food preparation based on food triggers, and coach on healthy diet recommendations after cancer treatment.
Detailed Description:
PRIMARY OBJECTIVES:
I. Administer and determine the feasibility of the personalized dietary intervention.
II. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors.
III. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery.
OUTLINE:
At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.
After completion of study, patients are followed up for 6 months.
I. Administer and determine the feasibility of the personalized dietary intervention.
II. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors.
III. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery.
OUTLINE:
At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.
After completion of study, patients are followed up for 6 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: